Postoperative Concurrent Chemoradiotherapy With Docetaxel for High-Risk Squamous Cell Carcinoma of Head and Neck，A Non-Randomized Phase II Trial

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 site in 1 country91 target enrollmentMarch 2016

ConditionsHead-and-neck Cancer Squamous Cell Carcinoma

InterventionsDocetaxel Intensity-modulated radiotherapy

DrugsDocetaxel

Overview

Phase: Phase 2
Intervention: Docetaxel
Conditions: Head-and-neck Cancer
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Enrollment: 91
Locations: 1
Primary Endpoint: Disease-free survival
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a non-randomized, phase II, open label study of postoperative concurrent chemoradiotherapy with docetaxel for high-risk squamous cell carcinoma of the head and neck(HNSCC).The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy with docetaxel in HNSCC patients.

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

February 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Responsible Party

Principal Investigator

Guopei Zhu

M.D.

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed squamous cell carcinoma of the head and neck.Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding nasopharynx, or sinuses)
•Gross total resection, with pathology demonstrating one or more of the following risk factors:
•Histologic extracapsular nodal extension
•Histologic involvement of ≥ 2 regional lymph nodes
•Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual
•No evidence of distant metastases
•No synchronous or concurrent head and neck primary tumors
•Karnofsky score over 60
•Adequate organ function including the following:
•Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l

Exclusion Criteria

•Evidence of distant metastasis
•Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
•Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
•Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
•Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Arms & Interventions

Docetaxel Group

Concurrent Chemoradiotherapy With Docetaxel

Intervention: Docetaxel

Docetaxel Group

Concurrent Chemoradiotherapy With Docetaxel

Intervention: Intensity-modulated radiotherapy

Outcomes

Primary Outcomes

Disease-free survival

Time Frame: 2 years

from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years

Secondary Outcomes

overall survival rate(2 years)
Acute toxicity profiles, graded according to the NCI CTCAE version 3.0(up to 6-7 weeks)
Late toxicity profiles, graded according to the NCI CTCAE version 3.0(up to 2 years)
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)